K252637 is an FDA 510(k) clearance for the Community Containers (Flap and Daisy). This device is classified as a Container, Sharps (Class II - Special Controls, product code MMK).
Submitted by Keter Canada, Inc. (Milton, CA). The FDA issued a Cleared decision on October 14, 2025, 55 days after receiving the submission on August 20, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K252637 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 2025 |
| Decision Date | October 14, 2025 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MMK - Container, Sharps |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |